Arterial plaque intracavitary directional rotary cutting device and using method thereof

Abstract

The invention provides an artery plaque intracavitary directional rotary cutting device and a using method thereof, and belongs to the technical field of medical instruments. The arterial plaque intracavitary directional rotary cutting device comprises a tool bit protection sleeve, a medicine storage part, a windmill type rotary cutting tool bit, a hollow spiral-line-shaped long-strip net bag structure recycling net, a metal supporting net, a guide pipe and a control unit. On the basis of having the advantages of a plaque excision device in the prior art, the artery plaque intracavity directional rotary cutting device further has the following advantages that (1) the rotary cutting position is accurate; (2) the medicine is suitable for treating patients with femoral popliteal lesion and below-knee arteriosclerosis obliterans; (3) the operation cost and the operation risk are low; (4) the stimulation and trauma to a patient are small in an operation; (5) the rotary cutting depth is long; (6) the cut plaques and chippings can be prevented from falling off; (7) the restenosis progress of blood vessels can be delayed, and inflammatory response and immune response caused by operations can be relieved; and (8) the device is easy to clean after operation.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to an intracavitary directional rotary cutting device for arterial plaque and a method for using the same. Background Art

[0002] Lower extremity arteriosclerosis obliterans is the most common peripheral arterial disease. Its basic pathological characteristics are abnormal lipid deposition and atherosclerotic plaque formation caused by vascular endothelial damage, which leads to luminal stenosis. Lower extremity arteriosclerosis obliterans is mainly manifested by a series of symptoms of arterial ischemia, including coldness of the affected limbs, pale skin, followed by intermittent claudication and rest pain. Severe ischemia may manifest as limb gangrene, tissue necrosis and infection. With the development of intraluminal vascular devices, endovascular surgery has become the main means of treating lower extremity arteriosclerosis obliterans. Balloon dilation of the diseased segment of the blood vessel and implantation of stents when necessary can effectively maintain the patency of the diseased segment of the lumen. However, long-term and chronic stimulation of balloon dilation and stent foreign bodies can lead to endothelial cell damage, smooth muscle cell proliferation and migration, induce chronic inflammation, activate the coagulation system and activate platelet function, and ultimately lead to postoperative restenosis. Conventional interventional treatments for lower extremity arterial disease include balloon dilatation and vascular stents. Although these methods can effectively open blood vessels, the plaques in the blood vessels cannot be eliminated, which directly affects the development of later lesions. Therefore, doctors around the world are thinking about how to directly expand the effective diameter of diseased blood vessels (without destroying the vascular structure) to achieve better treatment effects. Plaque rotary excision technology can effectively remove plaques in blood vessels. Plaque rotary excision systems have also stood out in various clinical trials. However, the existing plaque rotary excision system can only be applied to occlusive lesions of the femoral and popliteal artery segments, and no adaptive system has been developed for below-the-knee artery lesions; and the plaque rotary excision system causes great damage to the arterial intima after application. Drug-coated balloons are generally used to deal with restenosis caused by damaged intima. Restenosis treatment is difficult, the incidence of adverse events is high, and the amputation rate is high, which brings multiple physical, mental and economic blows to patients.

[0003] In order to solve the above problems, plaque removal is often used. The plaque removal device used in the prior art plaque removal is as follows: Fig.11 As shown, the plaque removal device 200 is used for intraluminal interventional treatment, and can remove plaques or hyperplastic intimal tissues in diseased blood vessels through directional cutting, expand the lumen capacity, reduce the intraluminal load, and inhibit the occurrence of vascular restenosis. The plaque removal device 200 includes a recovery module I, a removal blade II, and a catheter 30 connected in sequence. In actual use, a balloon is first used to pre-dilate the blood vessels corresponding to the position where the plaque needs to be removed in the patient, and then the catheter 30 is guided by a C14 guide wire into the position where the plaque needs to be removed in the patient's blood vessels, and the blade II is controlled to remove the plaque, and the removed plaque is stored in the recovery module I.

[0004] Current atherectomy devices have the following problems / disadvantages:

[0005] (1) The current plaque removal device requires a C14 guide wire to pass through (guided by C14). The C14 guide wire is too thin and has a low hardness, insufficient support force, and too high compliance, which is not conducive to positioning.

[0006] (2) The main characteristics of the lesions of patients with below-the-knee arteriosclerosis obliterans are long vascular lesions, thin vascular caliber, severe calcification, severe ischemic symptoms, and severe underlying diseases. Therefore, the treatment of below-the-knee arteriosclerosis obliterans is difficult, and the reocclusion rate and amputation rate are both high. However, for below-the-knee arteriosclerosis obliterans, no matter whether it is simple balloon dilatation angioplasty, stent, drug balloon or other intracavitary technologies, they cannot achieve the same therapeutic effect as femoropopliteal lesions in the treatment of below-the-knee lesions. In addition, when the current plaque removal device 200 performs plaque removal, the recovery module I is located at the front end of the removal blade II, blocking the removal blade II, making the application range of the plaque removal device 200 small, limited to the femoropopliteal artery segment, and cannot be used in below-the-knee artery lesions.

[0007] (3) Fig.11 As shown, in the current plaque removal device 200, since the removal blade II is at the tail end of the recovery module I, the applicable scenarios are limited. If the vascular lumen is narrow or even blocked, an additional balloon is still required for pre-dilation before the device can be used, which increases the cost and surgical risk. The removal blade II is at the rear side of the recovery module I. If the lumen is complex and the plaque is completely blocked, it cannot pass through, let alone perform rotary excision of the plaque.

[0008] Among them, the use of an additional balloon for pre-dilation refers to the use of a balloon catheter to pre-dilate a narrowed or blocked blood vessel during angioplasty to increase the diameter of the blood vessel lumen and prepare for subsequent interventional treatment or stent implantation. The effects of the balloon on the guide catheter include: (1) The guide catheter may be "de-bent" during forward delivery, which often occurs when the coaxiality of the guide catheter is poor, the operator's operation speed is fast, or the guide catheter is soft, the pre-curvature of the guide catheter is large, and the balloon is hard. It may cause unexpected dislocation of the operating system. (2) The guide catheter will be "pushed outward" during forward delivery, which often occurs when the balloon is located in the coronary artery with large forward delivery resistance or poor stability of the guide catheter. It may cause forced dislocation of the guide catheter. (3) The guide catheter will be "passively inserted deep" during retraction. It often occurs when the resistance to balloon retraction is large, which may cause the guide catheter to be inserted too deep, thereby causing passive damage to the proximal blood vessels. Summary of the invention

[0009] The present invention is made to solve the above-mentioned problems, and aims to provide an arterial plaque intracavitary directional rotary cutting device and a method of using the same.

[0010] The present invention provides an intracavitary directional rotary cutting device for arterial plaques, which has the following characteristics, including: a blade protection cover, which is a hollow truncated cone or conical structure with an opening on the side; a drug storage part, which can be opened and closed on the blade protection cover, and stores drugs required to be released in the blood vessel during surgery; a rotary cutting blade, which is a windmill-shaped blade, and is movably arranged in the blade protection cover along the axial direction thereof, so that when the opening of the blade protection cover is located at the plaque to be removed in the patient's blood vessel, the rotary cutting blade exposed at the opening rotary cuts the plaque and absorbs the removed plaque through the windmill-shaped structure; a recovery net, which is a hollow spiral linear strip net bag structure, for receiving and storing the vortex absorbed by the rotary cutting blade after rotary cutting. plaque; a metal support mesh is arranged on the side of the blade protection sleeve with a larger area of ​​the truncated cone or conical structure, and the recovery mesh is sleeved therein, so as to support the recovery mesh during the rotary cutting process; a catheter is connected to the end of the metal support mesh away from the blade protection sleeve, and is used for the C18 guide wire to pass through; a control unit is arranged at the end of the catheter away from the metal support mesh, the control unit is connected to the drug storage part to control the release of the drug in the drug storage part, the control unit is connected to the rotary cutting blade to control the rotary cutting process of the rotary cutting blade and the movement process of the rotary cutting blade along the axial direction of the blade protection sleeve, and the control unit is also connected to the metal support mesh and controls its rotation angle in the patient's blood vessel to adjust the rotary cutting direction of the rotary cutting blade.

[0011] The device for directional intracavitary excision of arterial plaque provided by the present invention may also have the following feature: the hollow gap of the recovery net of the hollow spiral linear long net bag structure is not greater than 1000 μm, thereby ensuring that the excised plaque stored therein will not leak.

[0012] The device for directional intracavitary excision of arterial plaque provided by the present invention may also have the following features: the circumferential spiral lines of the spiral net bag structure of the recovery net are all wound in the same clockwise or counterclockwise direction, thereby ensuring that it has a certain bending ductility. When the recovery net is full of plaques, the recovery net can be disassembled and bent to make it easy to clean out the plaques.

[0013] The device for directional intracavitary excision of arterial plaque provided by the present invention may also have the following feature: the metal support mesh is detachably connected to the catheter.

[0014] The arterial plaque intracavitary directional rotary cutting device provided by the present invention may also have the following characteristics: wherein the material of the rotary cutting blade head, the recovery net and the metal support net includes any one of stainless steel, chromium-molybdenum alloy or titanium alloy with good ductility and biocompatibility.

[0015] The arterial plaque intracavitary directional rotary cutting device provided by the present invention may also have the following features: wherein, the operating unit includes: an operating handle, which is arranged at the end of the catheter away from the metal support mesh; a high-frequency motor, which is arranged in the operating handle and connected to the rotary cutting cutter head through a spiral torque transmission module inserted in the catheter, and is used to drive the rotary cutting cutter head to rotate; a cutter head push rod, which is arranged on the operating handle and connected to the rotary cutting cutter head through the torque transmission module, thereby driving the rotary cutting cutter head to reciprocate along its axial direction inside the cutter head protective cover; a power switch, which is arranged on the operating handle and connected to the high-frequency motor, and is used to control the rotation process of the rotary cutting cutter head; a rotating knob and a strain pleat, which are both arranged on the operating handle and connected to the metal support mesh, and are used to adjust the rotation direction and angle of the metal support mesh; and a drug release button, which is arranged on the operating handle and connected to the drug storage part, and is used to control the opening and closing of the drug storage part to release the drug therein.

[0016] The arterial plaque intracavitary directional rotary cutting device provided by the present invention may also have the following features: wherein, a guide rail is provided on the operating handle, and the cutter head push rod is reciprocally movably arranged on the guide rail.

[0017] The device for directional intraluminal excision of arterial plaque provided by the present invention may also have the following features: the device also includes a flushing port, which is arranged on the operating handle. The flushing port is connected to the catheter through a passage penetrating the operating handle. When the device for directional intraluminal excision of arterial plaque is used up and the catheter is pulled out from the patient's blood vessel, the catheter can be cleaned by injecting liquid into the catheter through the flushing port.

[0018] The arterial plaque intracavitary directional rotary excision device provided by the present invention may also have the following features: wherein, the operating handle includes a first handle and a second handle that are interlocked with each other, the high-frequency motor, the blade push rod, the power switch and the drug release button are arranged on the first handle, the rotating knob, the strain fold and the flushing port are arranged on the second handle, and the second handle is connected to the end of the catheter away from the metal support mesh.

[0019] The present invention also provides a method for using any of the aforementioned intracavitary directional rotary cutting devices for arterial plaques, which has the following characteristics, including the following steps: S10, C18 guide wire enters the blood vessel: an incision is made at a set position in the patient's artery, and the C18 guide wire is inserted into the patient's artery; S20, DSA positioning and angle adjustment: the blade protection cover, metal support mesh and catheter of the intracavitary directional rotary cutting device for arterial plaques are inserted into the patient's artery under the guidance of the pre-entered C18 guide wire, and after the blade protection cover reaches the designated position for removing the plaque through imaging equipment, the rotation direction and angle of the metal support mesh are controlled by adjusting the rotating knob and the strain fold, so that the opening of the blade protection cover faces the plaque to be removed; S30, pushing the blade to rotary cut until the target lesion is unobstructed: pushing the blade to rotary cut The push rod causes the rotary cutting blade to move along its axial direction inside the blade head protective cover and expose a part of it at the opening of the blade head protective cover, then press the power switch to turn on the rotary cutting blade to perform rotary cutting on the plaque, and the cut plaque is vortexed into the recovery net by the rotary cutting blade for storage; S40, rotary cutting is completed and the drug is released: after rotary cutting is completed, the blade head protective cover, the metal support net and the catheter are pulled out from the patient's artery, and during the pulling-out process, the drug release button is pressed to release the drug in the drug storage part; S50, cleaning: after pulling out the catheter, the metal support net is removed from one end of the catheter, the recovery net inside the metal support net is taken out, and the plaque stored therein is cleaned by using a scoop, and then an external syringe is connected to the flushing port on the second handle, and liquid is poured into it to flush the catheter.

[0020] Functions and Effects of the Invention

[0021] According to the invention, an intracavitary directional rotary cutting device for arterial plaque comprises: a blade protection cover, which is a hollow truncated cone or conical structure with an opening on the side; a drug storage part, which can be opened and closed on the blade protection cover, and stores drugs required to be released in the blood vessel during surgery; a rotary cutting blade, which is a windmill-shaped blade, and is movably arranged in the blade protection cover along the axis direction thereof; when the opening of the blade protection cover is located at the plaque to be removed in the patient's blood vessel, the rotary cutting blade exposed at the opening rotary cuts the plaque and absorbs the removed plaque through the windmill-shaped structure; a recovery net, which is a hollow spiral strip net bag structure, for receiving and storing the plaque absorbed by the vortex after rotary cutting by the rotary cutting blade. block; a metal support mesh is arranged on the side of the blade protection sleeve with a larger area of ​​the truncated cone or conical structure, and the recovery mesh is sleeved therein, so as to support the recovery mesh during the rotary cutting process; a catheter is connected to the end of the metal support mesh away from the blade protection sleeve, and is used for the C18 guide wire to pass through; a control unit is arranged at the end of the catheter away from the metal support mesh, the control unit is connected to the drug storage part to control the release of the drug in the drug storage part, the control unit is connected to the rotary cutting blade to control the rotary cutting process of the rotary cutting blade and the movement process of the rotary cutting blade along the axial direction of the blade protection sleeve, and the control unit is also connected to the metal support mesh and controls its rotation angle in the patient's blood vessel to adjust the rotary cutting direction of the rotary cutting blade.

[0022] Therefore, the intracavitary directional rotary cutting device for arterial plaque of the present invention has the advantages of the prior art plaque removal device and also has the following beneficial effects:

[0023] (1) The device for directional intracavitary excision of arterial plaques of the present invention can ensure continuous blood perfusion. Diabetes combined with infrapopliteal artery disease usually leads to severe vascular calcification and poor collateral circulation. Microvascular disease in the foot causes circulatory disorders in patients, and thrombus formation is easy after PTA. Plaque resection does not destroy existing vascular branches and collateral vessels, and can open new vascular branches at the same time, further improving the vascular patency rate.

[0024] (2) Reduce the use rate of stents. Plaque removal can help avoid the need for stent implantation during PTA, including stents in special locations such as vascular bifurcations, reduce the risk of restenosis within the stent, and provide the possibility for subsequent treatment. The use of small balloons for pre-dilation of occluded blood vessels can help avoid the guidewire passing through the occluded diseased blood vessels under the intima, thereby reducing the risk of intraoperative complications such as vascular rupture and perforation.

[0025] (3) Achieve a higher limb salvage rate, improve limb salvage rate, alleviate symptoms such as rest pain, and improve quality of life.

[0026] (4) The diameter of the catheter entering the blood vessel is increased to allow the C18 guide wire to pass through. Based on the existing technology, a C18 guide wire with higher support force and correspondingly lower compliance is selected for guidance, which is conducive to better positioning of the excision and solves the problem of low support force of the guide wire and high compliance when the guide wire is passed through the catheter, resulting in low stability of the catheter, making the excision position more accurate.

[0027] (5) The rotary cutting blade is placed at the front end of the entire device, and a blade protection cover is installed in front of the rotary cutting blade to minimize additional damage during surgery.

[0028] (6) Placing the metal support mesh and the recovery mesh at the rear side of the rotary cutting blade and nesting them with the power shaft of the blade increases the depth of the blood vessels that can be rotary cut, thereby reaching the thinner lower limb arteries. Therefore, some below-the-knee artery thrombosis and calcification can be treated with this device.

[0029] (7) The anterior placement of the rotary cutting blade allows the device to be used directly for rotary cutting of blood vessels with severe stenosis or complete occlusion without the need for balloon pre-dilatation, thus reducing surgical risks and costs and improving the patient's quality of life.

[0030] (8) It can reduce the elastic retraction of the blood vessel wall. Different from the temporary plaque displacement caused by mechanical effects such as balloon dilatation, plaque resection can achieve the maximum "volume reduction" of the diseased blood vessels, effectively avoid the elastic retraction of the lumen, and thus achieve a higher technical success rate and vascular patency rate.

[0031] (9) The rotary cutting blade is placed forward, so that there is no excessive obstruction in front of the blade, and the depth of blood vessels that can be rotary cut is extended compared to the plaque removal device under the existing technology.

[0032] (10) The design of the four rotating parts of the windmill-type rotary cutting cutter head greatly improves the rotary cutting speed and the rotary cutting hit rate.

[0033] (11) The windmill-type rotary cutting blade, metal support mesh, and recovery mesh are designed so that the removed plaque can be absorbed by the vortex of the rotary cutting blade and stored in the recovery mesh. The hollow design can ensure that the removed plaque is tightly compacted in the recovery mesh (the fluid in the blood vessels is discharged through the hollow gaps of the recovery mesh during the removal process, while the plaque accumulates in the recovery mesh), reducing the risk of plaque debris falling off.

[0034] (12) The recycling net with a spiral strip net bag structure is convenient for subsequent cleaning. The plaque stored therein can be easily cleaned by disassembling the recycling net and bending or folding it in the opposite direction and spinning it.

[0035] (13) The design of the drug storage unit allows the operator or medical staff to release the required drugs during the process of removing the catheter after the excision is completed to cover the wound surface within the blood vessel, reduce the stimulation of the excision to the endothelium, inhibit restenosis, and reduce the probability of inflammation and immune response. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 It is a schematic structural diagram of an intracavitary directional rotary excision device for arterial plaque according to an embodiment of the present invention;

[0037] Figure 2 yes Figure 1 A magnified image of area A;

[0038] Figure 3 is a structural exploded diagram of a rotary cutting unit according to an embodiment of the present invention;

[0039] Figure 4 is a schematic structural diagram of a rotary cutting cutter head according to an embodiment of the present invention;

[0040] Figure 5 is a schematic structural diagram of a recycling network according to an embodiment of the present invention;

[0041] Figure 6 yes Figure 1 Enlarged view of area B;

[0042] Figure 7 yes Figure 1 Enlarged view of the middle C area;

[0043] Figure 8 yes Figure 7 A corresponding stereogram from another angle;

[0044] Fig. 9 This is a flowchart of a method for using an intracavitary directional rotary excision device for arterial plaque according to an embodiment of the present invention;

[0045] Fig.10 It is a schematic diagram of the process of plaque rotary excision by an intracavitary directional rotary excision device for arterial plaque according to an embodiment of the present invention;

[0046] Fig.11 It is a schematic diagram of the structure of a plaque removal device under the prior art when performing plaque removal in a blood vessel. DETAILED DESCRIPTION

[0047] In order to make the technical means, creative features, objectives and effects achieved by the present invention easy to understand, the following embodiments and drawings specifically illustrate an arterial plaque intracavitary directional rotary cutting device and its use method of the present invention.

[0048] <Example>

[0049] Figure 1 It is a schematic structural diagram of an intracavitary directional rotary excision device for arterial plaque according to an embodiment of the present invention; Figure 2 yes Figure 1 Magnified view of area A.

[0050] like Figure 1 and Figure 2 As shown, this embodiment provides an arterial plaque intracavitary directional rotary cutting device 100, including a rotary cutting unit 10, a drug storage unit 20, a catheter 30 and a manipulation unit 40.

[0051] Figure 3 It is a structural explosion diagram of the peeling unit of an embodiment of the present invention.

[0052] like Figure 1 to Figure 3 As shown, the peeling unit 10 includes a blade protection cover 11, a peeling blade 12, a recovery net 13 and a metal support net 14.

[0053] The blade protection cover 11 is a hollow conical structure with an opening 11a on the side.

[0054] Figure 4 It is a schematic structural diagram of a rotary cutting cutter head according to an embodiment of the present invention.

[0055] like Figure 2 to Figure 4 As shown, the rotary cutting blade 12 is made of a windmill-shaped titanium alloy and is movably arranged in the blade protection cover 11 along the axial direction thereof. When the opening 11a of the blade protection cover 11 is located at the plaque to be removed in the patient's blood vessel, the rotary cutting blade 12 exposed at the opening 11a rotary cuts the plaque and absorbs the cut plaque through its windmill-shaped structure vortex.

[0056] Figure 5 It is a schematic structural diagram of a recovery network according to an embodiment of the present invention.

[0057] like Figure 2 to Figure 5 As shown, the recovery net 13 is a hollow spiral strip net bag structure, which is used to receive and store the plaques absorbed by the vortex after the peeling cutter head 12 peels.

[0058] In this embodiment, the spiral lines 13a of the spiral net structure of the recovery net 13 are all made of titanium alloy and are wound in the same clockwise or counterclockwise direction, so as to ensure that it has a certain bending ductility. When the recovery net 13 is full of plaques, the recovery net 13 is disassembled and bent or folded in the opposite direction to make it easy to clean out the plaques.

[0059] The hollow gap of the recovery net 13 of the hollow spiral strip net bag structure is no more than 1000 μm, thereby ensuring that the peeled plaques stored therein will not leak.

[0060] Figure 6 yes Figure 1 Magnified view of area B.

[0061] like Figure 1 , Figure 2 , Figure 3 , Figure 5 as well as Figure 6 As shown, the metal support mesh 14 is arranged on the larger side of the conical blade protection cover 11, and the recovery mesh 13 is sleeved therein, so as to support the recovery mesh 13 during the peeling process. Specifically, in this embodiment, the metal support mesh 14 is made of titanium alloy.

[0062] like Figure 1 and Figure 2 As shown, the drug storage part 20 is disposed on the blade protection cover 11 in an openable and closable manner, and the drug storage part 20 stores drugs required to be released into the blood vessels during surgery.

[0063] like Figure 1 and Figure 2 As shown, the catheter 30 is detachably connected to the end of the metal support mesh 14 away from the blade protection cover 11, and is specially used for matching and passing the C18 guide wire.

[0064] Specifically, in this embodiment, in the catheter section 30, a C18 guide wire (not shown in the figure) is inserted into the catheter 30 and provides direction guidance for the catheter 30; in the metal support mesh section 14, the C18 guide wire is parallel to the outer periphery of the metal support mesh section 14. (The setting, relevant structure and use method of the guide wire are all based on the public existing technology, and its specific structure is not drawn and / or detailed in this embodiment)

[0065] Figure 7 yes Figure 1 Enlarged view of the middle C area; Figure 8 yes Figure 7 The corresponding stereogram from another angle.

[0066] like Figure 1 , Figure 7 as well as Figure 8 As shown, the operating unit 40 includes an operating handle 41, a high-frequency motor (not shown in the figure), a guide rail 42, a blade push rod 43, a power switch 44, a rotating knob 45, a strain pleat 46, a drug release button 47 and a flushing port 48.

[0067] The operating handle 41 includes a first handle 411 and a second handle 412 that are clamped together. The second handle 412 is connected to an end of the catheter 30 that is away from the metal support mesh 14 .

[0068] A high-frequency motor (not shown) is disposed in the first handle 411 and is connected to the rotary cutter head 12 via a spiral torque transmission module (not shown) passing through the operating handle 41 and the catheter 30, so as to drive the rotary cutter head 12 to rotate.

[0069] Specifically, in the section of the conduit 30, the torque transmission module (not shown in the figure) in this embodiment is inserted therein; in the section of the metal support net 14, the torque transmission module is inserted between the metal support net 14 and the recovery net 13. The torque transmission module transmits the rotational power generated by the high-frequency motor to the rotary cutting cutter head 12 to rotate it. (The torque transmission module is an existing technology that has been publicly used, and its specific structure will not be described in detail in this embodiment)

[0070] like Figures 1 to 8 As shown:

[0071] The guide rail 42 is disposed on the first handle 411; the blade push rod 43 is reciprocatably disposed on the guide rail 42 and is connected to the rotary cutting blade 12 through a torque transmission module. When the blade push rod 43 reciprocates on the guide rail 42, the rotary cutting blade 12 is driven to reciprocate along the axial direction inside the blade protection cover 11 (retracted inside the blade protection cover 11 or partially exposed from the opening 11a of the blade protection cover 11 to perform rotary cutting on the plaque).

[0072] The power switch 44 is disposed on the first handle 411 and connected to the high-frequency motor for controlling the rotation process of the rotary cutting blade 12 .

[0073] The rotating knob 45 and the strain pleat 46 are both arranged at the connection with the catheter 30 on the second handle 412, and are connected to the metal support net 14 through a transmission module arranged in parallel with the catheter 30, so as to adjust the rotation angle and direction of the metal support net 14 (i.e., the direction of the opening 11a of the corresponding blade protection cover 11). The rotating knob 45, the strain pleat 46 and the corresponding transmission module in this embodiment are all existing technologies that are currently in a state of public use, and their specific structures are not described in detail in this embodiment.

[0074] The drug release button 47 is disposed on the first handle 411 and connected to the drug storage portion 20 , and is used to control the opening and closing of the drug storage portion 20 to release the drugs therein.

[0075] The flushing port 48 is provided on the second handle 412, and is connected to the catheter 30 through the passageway penetrating the first handle 411 and the second handle 412. When the intracavitary directional rotary cutting device 100 is used and the catheter 30 is withdrawn from the patient's blood vessel, the catheter 30 can be cleaned by injecting liquid into the catheter 30 through the flushing port 48.

[0076] Fig. 9This is a flowchart of a method for using an intracavitary directional rotary excision device for arterial plaque according to an embodiment of the present invention; Fig.10 It is a schematic diagram of the process of plaque rotary excision by a device for directional rotary excision of arterial plaque in the cavity of an embodiment of the present invention.

[0077] like Figures 1 to 10 As shown, this embodiment provides a method for using the corresponding arterial plaque intracavitary directional rotary cutting device 100, comprising the following steps:

[0078] S10, C18 guidewire enters the blood vessel:

[0079] An incision is made at the set position of the patient's artery, and a C18 guide wire is inserted deep into the patient's artery.

[0080] S20, DSA positioning and adjustment angle:

[0081] The blade protection cover 11, metal support mesh 14 and catheter 30 of the intracavitary directional excision device for arterial plaque are inserted deep into the patient's artery under the guidance of the pre-entered C18 guide wire, and after confirming through imaging equipment that the blade protection cover 11 has reached the designated position for removing the plaque, the rotation direction and angle of the metal support mesh 14 are controlled by adjusting the rotating knob 45 and the strain fold 46, so that the opening 11a of the blade protection cover 11 faces the plaque to be removed.

[0082] S30, push the blade to cut until the target lesion is clear:

[0083] After pushing the blade push rod 43 so that the rotary cutting blade 12 moves axially inside the blade protection cover 11 and partially exposes a portion of the blade protection cover 11 at the opening 11a, press the power switch 44 to turn on the rotary cutting blade 12 to rotary cut the plaque. The rotary cut plaque is vortexed by the rotary cutting blade 12 into the recovery net 13 for storage.

[0084] S40, rotary cutting is completed and the drug is released:

[0085] After the excision is completed, the blade protection cover 11, the metal support mesh 14 and the catheter 30 are pulled out from the patient's artery, and during the extraction process, the drug release button 47 is pressed to release the drug in the drug storage unit to cover the wound surface in the blood vessel, reduce the stimulation of the blood vessel endothelium caused by excision, inhibit restenosis, and effectively reduce the inflammatory response and immune response to the surgical operation.

[0086] S50, Cleaning:

[0087] After the catheter 30 is pulled out, the metal support net 14 is removed from one end of the catheter 30, and the recovery net 13 in the metal support net 14 is taken out, and the plaque stored therein is cleaned out by using a scoop. At the same time, the recovery net 13 can also be bent or folded in the opposite direction to make it easier to clean out the plaque therein. Then, an external syringe is connected to the flushing port 48 on the second handle 412, and liquid is poured into it to flush the catheter 30.

[0088] Functions and Effects of the Embodiments

[0089] According to the embodiment, an intracavitary directional rotary cutting device for arterial plaque is provided, which comprises: a blade protection cover, which is a hollow truncated cone or conical structure with an opening on the side; a drug storage part, which can be opened and closed on the blade protection cover, and stores drugs required to be released in the blood vessel during surgery; a rotary cutting blade, which is a windmill-shaped blade, and is movably arranged in the blade protection cover along the axis direction. When the opening of the blade protection cover is located at the plaque to be removed in the patient's blood vessel, the rotary cutting blade exposed at the opening rotary cuts the plaque and absorbs the removed plaque through the windmill-shaped structure; a recovery net, which is a hollow spiral strip net bag structure, is used to receive and store the plaque absorbed by the vortex after rotary cutting by the rotary cutting blade. block; a metal support mesh is arranged on the side of the blade protection sleeve with a larger area of ​​the truncated cone or conical structure, and the recovery mesh is sleeved therein, so as to support the recovery mesh during the rotary cutting process; a catheter is connected to the end of the metal support mesh away from the blade protection sleeve, and is used for the C18 guide wire to pass through; a control unit is arranged at the end of the catheter away from the metal support mesh, the control unit is connected to the drug storage part to control the release of the drug in the drug storage part, the control unit is connected to the rotary cutting blade to control the rotary cutting process of the rotary cutting blade and the movement process of the rotary cutting blade along the axial direction of the blade protection sleeve, and the control unit is also connected to the metal support mesh and controls its rotation angle in the patient's blood vessel to adjust the rotary cutting direction of the rotary cutting blade.

[0090] Therefore, the intracavitary directional rotary cutting device of arterial plaque in this embodiment has the following beneficial effects:

[0091] (1) The device for intracavitary directional excision of arterial plaques of this embodiment can ensure continuous blood perfusion. Diabetes combined with infrapopliteal artery disease usually leads to severe vascular calcification and poor collateral circulation. Microvascular disease in the foot causes circulatory disorders in patients, and thrombosis is prone to form after PTA. Plaque resection does not destroy existing vascular branches and collateral vessels, and can open new vascular branches at the same time, further improving the vascular patency rate.

[0092] (2) Reduce the use rate of stents. Plaque removal can help avoid the need for stent implantation during PTA, including stents in special locations such as vascular bifurcations, reduce the risk of restenosis within the stent, and provide the possibility for subsequent treatment. The use of small balloons for pre-dilation of occluded blood vessels can help avoid the guidewire passing through the occluded diseased blood vessels under the intima, thereby reducing the risk of intraoperative complications such as vascular rupture and perforation.

[0093] (3) Achieve a higher limb salvage rate, improve limb salvage rate, alleviate symptoms such as rest pain, and improve quality of life.

[0094] (4) The diameter of the catheter entering the blood vessel is increased to allow the C18 guide wire to pass through. Based on the existing technology, a C18 guide wire with higher support force and correspondingly lower compliance is selected for guidance, which is conducive to better positioning of the excision and solves the problem of low support force of the guide wire and high compliance when the guide wire is passed through the catheter, resulting in low stability of the catheter, making the excision position more accurate.

[0095] (5) The rotary cutting blade is placed at the front end of the entire device, and a blade protection cover is installed in front of the rotary cutting blade to minimize additional damage during surgery.

[0096] (6) Placing the metal support mesh and the recovery mesh at the rear side of the rotary cutting blade and nesting them with the power shaft of the blade increases the depth of the blood vessels that can be rotary cut, thereby reaching the thinner lower limb arteries. Therefore, some below-the-knee artery thrombosis and calcification can be treated with this device.

[0097] (7) The anterior placement of the rotary cutting blade allows the device to be used directly for rotary cutting of blood vessels with severe stenosis or complete occlusion without the need for balloon pre-dilatation, thus reducing surgical risks and costs and improving the patient's quality of life.

[0098] (8) It can reduce the elastic retraction of the blood vessel wall. Different from the temporary plaque displacement caused by mechanical effects such as balloon dilatation, plaque resection can achieve the maximum "volume reduction" of the diseased blood vessels, effectively avoid the elastic retraction of the lumen, and thus achieve a higher technical success rate and vascular patency rate.

[0099] (9) The rotary cutting blade is placed forward, so that there is no excessive obstruction in front of the blade, and the depth of blood vessels that can be rotary cut is extended compared to the plaque removal device under the existing technology.

[0100] (10) The design of the four rotating parts of the windmill-type rotary cutting cutter head greatly improves the rotary cutting speed and the rotary cutting hit rate.

[0101] (11) The windmill-type rotary cutting blade, metal support mesh, and recovery mesh are designed so that the removed plaque can be absorbed by the vortex of the rotary cutting blade and stored in the recovery mesh. The hollow design can ensure that the removed plaque is tightly compacted in the recovery mesh (the fluid in the blood vessels is discharged through the hollow gaps of the recovery mesh during the removal process, while the plaque accumulates in the recovery mesh), reducing the risk of plaque debris falling off.

[0102] (12) The recycling net with a spiral strip net bag structure is convenient for subsequent cleaning. The plaque stored therein can be easily cleaned by disassembling the recycling net and bending or folding it in the opposite direction and spinning it.

[0103] (13) The design of the drug storage unit allows the operator or medical staff to release the required drugs during the process of removing the catheter after the excision is completed to cover the wound surface within the blood vessel, reduce the stimulation of the excision to the endothelium, inhibit restenosis, and reduce the probability of inflammation and immune response.

[0104] Furthermore, the hollow gap of the recycling net of the hollow spiral strip net bag structure is no more than 1000 μm. This configuration matches the size of the removed plaque debris, thereby ensuring that the peeled plaque stored therein will not leak.

[0105] Furthermore, the spiral lines of the spiral net bag structure of the recovery net are all wound in the same clockwise or counterclockwise direction. In this way, the recovery net with the spiral strip net bag structure is convenient for subsequent cleaning. The plaque stored therein can be conveniently cleaned by disassembling the recovery net and bending or folding it in the opposite direction and spinning it.

[0106] Furthermore, the metal support net is detachably connected to the conduit, which is convenient for disassembly, cleaning and disinfection of the device after use.

[0107] Furthermore, the material of the rotary cutting blade, the recovery net and the metal support net includes any one of stainless steel, chromium-molybdenum alloy or titanium alloy with good ductility and biocompatibility. Such a configuration makes the intracavitary directional rotary cutting device for arterial plaque less irritating to the patient's blood vessels during use, reducing the probability of inflammation and immune response.

[0108] Further, the manipulation unit includes: a manipulation handle, which is arranged at one end of the catheter away from the metal support net; a high-frequency motor, which is arranged in the manipulation handle and connected to the rotary cutting cutter head through a spiral torque transmission module inserted in the catheter, and is used to drive the rotary cutting cutter head to rotate; a cutter head push rod, which is arranged on the manipulation handle and connected to the rotary cutting cutter head through the torque transmission module, thereby driving the rotary cutting cutter head to reciprocate along the axis direction inside the cutter head protective cover; a power switch, which is arranged on the manipulation handle and connected to the high-frequency motor, and is used to control the rotation process of the rotary cutting cutter head; a rotating knob and a strain fold, which are both arranged on the manipulation handle and connected to the metal support net, and are used to adjust the rotation direction and angle of the metal support net; and a drug release button, which is arranged on the manipulation handle and connected to the drug storage part, and is used to control the opening and closing of the drug storage part to release the drug therein. The manipulation handle has a guide rail, and the cutter head push rod is reciprocatingly arranged on the guide rail. Such a configuration enables the operator or medical staff to more efficiently control the use and rotary cutting process of the entire arterial plaque intracavitary directional rotary cutting device.

[0109] Furthermore, the intracavitary directional rotary cutting device for arterial plaques also includes a flushing port, which is arranged on the operating handle and connected to the catheter through a passageway penetrating the operating handle. With such arrangement, when the intracavitary directional rotary cutting device for arterial plaques is used up and the catheter is withdrawn from the patient's blood vessel, it is convenient for the operator or medical staff to perfuse liquid into the catheter through the flushing port to clean the catheter.

[0110] Furthermore, the operating handle includes a first handle and a second handle that are mutually engaged, a high-frequency motor, a blade push rod, a power switch and a drug release button are arranged on the first handle, a rotating knob, a strain fold and a flushing port are arranged on the second handle, and the second handle is connected to the end of the catheter away from the metal support net. Such an arrangement makes the operating handle modular and easy to disassemble, reduces the integration of the mechanical structure of the entire arterial plaque intracavitary directional rotary cutting device, and facilitates subsequent maintenance and repair.

[0111] Those skilled in the art should understand that the present invention is not limited to the above embodiments, and the above embodiments and descriptions are only for explaining the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, and these changes and improvements fall within the scope of the present invention to be protected. The scope of protection of the present invention is defined by the attached claims and their equivalents.

Claims

1. An intracavitary directional rotary cutting device for arterial plaque, characterized in that: include: The blade protection cover is a hollow truncated cone or cone-shaped structure with an opening on the side; A drug storage unit is disposed on the blade protection cover in an openable and closable manner, and the drug storage unit stores drugs required to be released into the blood vessels during surgery; The rotary cutting blade is of a pinwheel type and is movably arranged in the blade protective cover along the axis direction thereof. When the opening of the blade protective cover is located at the plaque to be removed in the patient's blood vessel, the rotary cutting blade exposed at the opening rotary cuts the plaque and absorbs the cut plaque through the pinwheel type structure vortex; The recovery net is a hollow spiral strip net bag structure, which is used to receive and store the plaques absorbed by the vortex after the rotary cutting head is rotary cut; A metal support net is arranged on the side of the cutter head protection cover with a larger area of ​​the truncated cone or cone structure, and the recovery net is sleeved therein, so as to support the recovery net during the peeling process; A catheter is connected to the end of the metal support mesh away from the blade protection cover, and is used for the C18 guide wire to pass through; A control unit is arranged at one end of the catheter away from the metal support mesh, the control unit is connected to the drug storage part to control the release of the drug in the drug storage part, the control unit is connected to the rotary cutting cutter head to control the rotary cutting process of the rotary cutting cutter head and the axial movement process of the rotary cutting cutter head along the cutter head protective cover, and the control unit is also connected to the metal support mesh and controls its rotation angle in the patient's blood vessel to adjust the rotary cutting direction of the rotary cutting cutter head.

2. The device for directional intracavitary excision of arterial plaque according to claim 1, characterized in that: in, The hollow gaps of the recovery net of the hollow spiral strip net bag structure are no larger than 1000 μm, thereby ensuring that the peeled plaques stored therein will not leak.

3. The device for directional intracavitary excision of arterial plaque according to claim 1, characterized in that: in, The spiral lines of the spiral net bag structure of the recycling net are all wound in the same clockwise or counterclockwise direction, so as to ensure that it has a certain bending ductility. When the plaques are fully stored inside the recovery net, the recovery net can be disassembled and bent so that the plaques therein can be easily cleaned out.

4. The device for directional intracavitary excision of arterial plaque according to claim 1, characterized in that: in, The metal support mesh is detachably connected to the catheter.

5. The device for directional intracavitary excision of arterial plaque according to claim 1, characterized in that: in, The material of the rotary cutting blade head, the recovery net and the metal support net includes any one of stainless steel, chromium-molybdenum alloy or titanium alloy with good ductility and biocompatibility.

6. The device for directional intraluminal excision of arterial plaque according to claim 1, Features: in, The control unit comprises: A manipulation handle is arranged at an end of the catheter away from the metal support mesh; A high-frequency motor is disposed in the operating handle and connected to the rotary cutting cutter head via a spiral torque transmission module passing through the conduit, so as to drive the rotary cutting cutter head to rotate; A cutter head push rod is arranged on the operating handle and is connected to the rotary cutting cutter head through the torque transmission module, thereby driving the rotary cutting cutter head to reciprocate along the axial direction of the cutter head inside the cutter head protective sleeve; A power switch, disposed on the operating handle and connected to the high-frequency motor, for controlling the rotation process of the rotary cutting cutter head; A rotating knob and a strain pleat are both arranged on the operating handle and connected to the metal support net, and are used to adjust the rotation direction and angle of the metal support net; and A drug release button is arranged on the operating handle and connected to the drug storage part, and is used to control the opening and closing of the drug storage part so as to release the drug therein.

7. The device for directional intracavitary excision of arterial plaque according to claim 6, characterized in that: in, The operating handle is provided with a guide rail. The cutter head push rod is reciprocatably arranged on the guide rail.

8. The device for directional intracavitary excision of arterial plaque according to claim 6, characterized in that: in, The arterial plaque intracavitary directional rotary cutting device also includes a flushing port, The flushing port is arranged on the operating handle, and the flushing port is connected to the conduit through a passage penetrating the operating handle. When the arterial plaque intracavitary directional rotary cutting device is used up and the catheter is withdrawn from the patient's blood vessel, the catheter can be cleaned by injecting liquid into the catheter through the flushing port.

9. The device for directional intracavitary excision of arterial plaque according to claim 6, characterized in that: in, The operating handle comprises a first handle and a second handle which are mutually engaged. The high-frequency motor, the blade push rod, the power switch and the drug release button are arranged on the first handle. The rotating knob, the strain pleats and the flushing port are arranged on the second handle. The second handle is connected to an end of the catheter away from the metal support mesh.

10. The method for using the intraluminal directional rotary cutting device for arterial plaque according to any one of claims 1 to 9, comprising the following steps: S10, C18 guidewire enters the blood vessel: an incision is made at the set position of the patient's artery, and the C18 guidewire is inserted deep into the patient's artery; S20, DSA positioning and angle adjustment: the blade protection cover, the metal support mesh and the catheter of the intracavitary directional rotary excision device for arterial plaque are inserted into the patient's artery under the guidance of the C18 guide wire that has been inserted in advance, and after the blade protection cover reaches the designated position for removing the plaque through an imaging device, the rotation direction and angle of the metal support mesh are controlled by adjusting the rotating knob and the strain fold, so that the opening of the blade protection cover faces the plaque to be removed; S30, pushing the blade head to perform rotary cutting until the target lesion is clear: pushing the blade head push rod so that the rotary cutting blade head moves along the axial direction inside the blade head protective cover and exposes a portion of the blade head at the opening of the blade head protective cover, pressing the power switch to turn on the rotary cutting blade head to perform rotary cutting on the plaque, and the rotary cut plaque is vortexed by the rotary cutting blade head into a recovery net for storage; S40, the rotary cutting is completed and the drug is released: after the rotary cutting is completed, the blade protection cover, the metal support mesh and the catheter are withdrawn from the patient's artery, and during the withdrawal process, a drug release button is pressed to release the drug in the drug storage part; S50, cleaning: after the catheter is pulled out, the metal support mesh is disassembled from one end of the catheter, the recovery mesh inside the metal support mesh is taken out, and the plaque stored therein is cleaned by using a scoop, and then an external syringe is connected to the flushing port on the second handle, and liquid is poured into the flushing port to flush the catheter.

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